DERBY >> Griffin Hospital is warning that insulin pens used on more than 3,000 diabetes patients hospitalized there over the past six years may have been misused, exposing the patients to hepatitis B, hepatitis C and HIV.

The warning is for any patients who were hospitalized at the Derby hospital and were prescribed insulin pens between Sept. 1, 2008, and May 7, 2014.

“We believe that insulin pens meant to be used on a single patient may have been used on more than one patient,” said Patrick Charmel, the hospital’s president and chief executive officer, on Friday at a noon press conference.

Charmel called the breach a “serious safety issue,” though he said there is no evidence any disease transmission has occurred to any patient.

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The hospital said there is a small likelihood that any patient contracted a disease.

“Frankly it shouldn’t have happened but it did,” Charmel said. “We feel that it can happen elsewhere, that’s why we’re making it public.”

A letter was sent Friday to 3,149 patients to notify them of that they need to be tested for hepatitis B, hepatitis C and HIV, Charmel said.

Dr. Howard Quentzel, the hospital’s chief of infections diseases, said these three diseases are the only ones that the hospital is concerned about because of how they are transmitted. He said the new transmission of the diseases as a result of the misuse is highly unlikely.

The hospital is recommending that patients be tested within the next 30 days. The hospital will pay for the testing, either at Griffin or at another facility, and the cost of any treatment required, Charmel said.

The danger, hospital officials said, is that blood or skin cells could’ve backflowed into the pen, which is why it’s meant only for one patient.

“To the extent that improper use of pens did occur, the hospital is certain that pen needles were not reused because Griffin Hospital has always used safety needles that prevent a needle from being used for more than a single injection,” the hospital said. “However, even when using a new needle, the possibility exists that a pen’s insulin cartridge can be contaminated through the backflow of blood or skin cells from one patient, and thus could potentially transmit an infection if used on another patient.”

Similar misuse of insulin pens—designed mainly for home use—have been reported at hospitals around the country over the past few years, including in March at a Long Island hospital. The increase in hospitals using the insulin pens, and the risk of misuse, has caused several health agencies, including the Centers for Disease Control (CDC), to send out information to health facilities about how to properly use the devices.

Griffin Hospital stopped using the insulin pens May 7.

State launches probe of hospital

The state Department of Public Health, in its regulatory authority, has started an investigation into the hospital, according to spokesman William Gerrish.

“Protection from infections, including blood borne pathogens, is a basic expectation anywhere health care is provided,” Gerrish said in an email. “According to the CDC, use of insulin pens for more than one person imposes unacceptable risk and should never happen. DPH takes the unsafe use of medical devices seriously.”

DPH also notified the Centers for Medicare and Medicaid about the possible misuse of the insulin pens, and sent Connecticut health care providers information from the CMS and the CDC about the proper use of insulin pens.

DPH officials said healthcare facilities “should review their policies and procedures and educate their staff regarding safe use of insulin pens.” Gerrish said DPH learned about the hospital’s investigation on Thursday.

According to Charmel, the misuse was discovered during a routine “safety huddle,” after a nurse questioned a pharmacist about whether the insulin pens could be used on more than one patient. The nurse said the question arose from a recent news article about an incident at another hospital. Charmel said, after that meeting, an investigation was launched.

Recently, similar disclosures have been made about the misuse of insulin pens at hospitals in Long Island and Buffalo, N.Y., The American Diabetes Association released a report in November about the risk of reusing insulin pens on multiple patients.

At Griffin, Charmel said, five nurses have said they either used the single-use insulin pens on more than one patient, or witnessed the misuse.

Charmel said the five nurses will be disciplined but the punishment will not be punitive. He said education could have been heightened around the product, but that evidence has shown there is room for error.

“In retrospect, could we have been more diligent? Yes,” Charmel said. “Education alone won’t prevent misuse.”

What are insulin pens?

According to the hospital, “insulin pens are injector devices that contain a multi-dose vial of insulin, also referred to as an insulin cartridge.” The insulin pens are used by “thousands of hospitals” across the country and are intended for single-person use only. They are designed to allow for the delivery of multiple doses.

“The single-use, retractable needle that attaches to the insulin pen is removable, allowing reuse of the pen-like injector with a new sterile safety needle for each use,” according to the hospital’s release.

The hospital said new needles were always used, but the pen-like injector may have been used on more than one patient.

In the release, the hospital said insulin pens were used for hospitalized patients only.

The pens have been used since 2008, because they are less painful for patients and considered to be a safer way to deliver insulin, although the pens are typically recommended only for home use.

The “Flexpens” are made by Novo Nordisk and state on the packaging that they are meant for use by only one person.

CDC, other health agencies have issued warnings about misuse

Dr. Melissa K. Schaefer, of the CDC, said there shouldn’t be a large margin for error with these insulin pens, but that recent events have shown that facilities should be more diligent in ensuring the safety of patients.

“I think it’s facilities learning from the mistakes of others,” Schaefer said. “Do you have this type of device in your facility? And if you do, what safeguards do you have in place to ensure that your facility is using them as safely as they’re intended?”

Schaefer couldn’t confirm that this sort of misuse is on the rise, but reports of this kind of cross contamination are becoming more frequent she said.

In Long Island in March, South Nassau Communities Hospital informed 4,247 patients that they should be tested for diseases after misuse was reported.

“I don’t know where the misconception or misunderstanding with providers is,” she said. “Essentially this is syringe misuse... Changing the needle does not make an insulin needle or syringe safe on an additional patient. Period.”

The CDC is not working with Griffin Hospital on this particular incident, but Schaefer said the facility seems to be following the suggested procedures for this type of exposure.

‘Safety huddle’ helped identify problem

The Connecticut Hospital Association said in a statement that it commends the hospital’s leadership for taking full responsibility and steps to address the issue.

“The climate we are trying to achieve is one in which staff are empowered to raise concerns proactively about practices that may cause risk to patients,” the hospital association said. “Another element of highly reliable organizations is the concept of transparency, in which we talk openly about mistakes that are made, fix them promptly, and take action to ensure they don’t happen again.”

The CHA said the daily safety huddle, when the information about the possible misuse of the pens was brought forward, are part of a “high reliability” initiative that hospitals across the state are taking.

“High reliability is a safety methodology used in many complex organizations around the world to reduce the risk of preventable harm,” the hospital association said. “One of the key elements of high reliability is the institution of a daily safety huddle, during which time staff are encouraged to discuss concerns and issues.”

Charmel said Griffin Hospital has been recognized nationally for it’s transparency.

“We understand that this is going to shape people trust in the organization,” Charmel said.

Hotline set up for patients

Griffin Hospital has established phone lines that will be staffed from 7 a.m. to 10 p.m., seven days a week. The hot line numbers are 203-732-1411 and 203-732-1340.

“Patients that call these phone lines can coordinate an appointment for confidential testing or speak with a nurse or pharmacist to answer any questions,” the hospital said. “There will be no charge for any screenings, testing, or counseling provided by Griffin Hospital related to this matter, and testing results will be provided within seven days to patients and their primary care physicians.”

Tom Cleary contributed to this report. Reach Mercy A. Quaye at 203-789-5695. Have questions, feedback or ideas about our news coverage? Connect directly with the editors of the New Haven Register at AskTheRegister.com.

About the Author

Reporter Mercy Quaye covers statewide breaking news for The New Haven Register, The Middletown Press, and The Register Citizen. Reach the author at mquaye@registercitizen.com
or follow Mercy A. on Twitter: @Mrs_WriteNow.